Empowering Rural African American Women and Communities to Improve Diabetes Outcomes

Type 2 Diabetes Mellitus Clinical Trial

— EMPOWER  

Official title:

Empowering Rural African American Women and Communities to Improve Diabetes Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806194
• Other study ID #: 212196
• Status: Completed
• Phase: N/A
• First received: December 5, 2012
• Last updated: January 19, 2016
• Start date: January 2012
• Est. completion date: July 2014

Study information

• Verified date: January 2016
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The EMPOWER diabetes program is a year-long, community-based program designed to enhance diabetes management in rural African American women with uncontrolled diabetes. The treatment is delivered by community peers and follows a relative Small Changes approach.

Description:

East Carolina University, along with established community partners, is implementing a community-based and culturally-tailored intervention to reduce diabetes disparities in 200 rural African American women with uncontrolled diabetes using our unique behaviorally-centered small changes approach to diabetes self-management, delivered by community health workers. The focus is on moderation and patient-selected small changes in eating, activity, and care management that decrease feelings of deprivation and failure and increase feelings of confidence and success. The intervention is specifically tailored to overcome psychosocial and environmental barriers to behavioral change through a strong focus on emotional, cultural, and social factors related to eating, activity, and medications. Objectives for the proposed project are to: 1) implement and evaluate the effectiveness of this tailored small changes intervention; 2) examine the impact of this approach on psychological mediators of behavioral choices in diabetes; 3) implement and evaluate public policy and built environment advocacy strategies; and 4) build, sustain, and disseminate a business-sustainable care model. The study will be a randomized prospective trial comparing the small changes intervention, delivered in 16 sessions by community health workers, to a control group receiving 16 mailings of diabetes educational materials. We hypothesize that there will be a greater improvement in behavioral choices and glycemic control in the intervention group compared to the control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

• African American female,

• age 19 - 75yr.,

• with Type 2 diabetes mellitus and

• living in or near Bertie, Edgecombe, and Pitt counties in eastern NC

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Lifestyle Counseling
Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers
• Educational Control Arm
16 mailings of diabetes educational materials but no regular contact with community health workers

Locations

Country	Name	City	State
United States	East Carolina University	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Cummings DM, Lutes L, Littlewood K, DiNatale E, Hambidge B, Schulman K, Morisky DE. Regimen-Related Distress, Medication Adherence, and Glycemic Control in Rural African American Women With Type 2 Diabetes Mellitus. Ann Pharmacother. 2014 Jun 5;48(8):970-977. [Epub ahead of print] — View Citation

Cummings DM, Lutes LD, Littlewood K, Dinatale E, Hambidge B, Schulman K. EMPOWER: a randomized trial using community health workers to deliver a lifestyle intervention program in African American women with Type 2 diabetes: design, rationale, and baseline characteristics. Contemp Clin Trials. 2013 Sep;36(1):147-53. doi: 10.1016/j.cct.2013.06.006. Epub 2013 Jun 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood pressure	Blood pressure	6 months	No
Other	Blood Pressure	Blood pressure	12 Months	No
Primary	Change in Hemoglobin A1c	Glycosylated hemoglobin	6 months	No
Primary	Change in Hemoglobin A1c	Glycosylated hemoglobin	12 Months	No
Secondary	Change in Weight	Body weight	6 Months	No
Secondary	Change in Weight	Body Weight	12 Months	No